Health care employers are not alone in feeling overwhelmed by the constantly changing legal status of the various federal vaccine mandates. On Thursday afternoon, the Supreme Court made its rulings on two preliminary...more
1/18/2022
/ Biden Administration ,
Biden v Missouri ,
Centers for Medicare & Medicaid Services (CMS) ,
Constitutional Challenges ,
Coronavirus/COVID-19 ,
Employer Mandates ,
Health Care Providers ,
Healthcare Facilities ,
Interim Final Rules (IFR) ,
Medicaid ,
Medicare ,
National Federation of Independent Business v Department of Labor and OSHA ,
OSHA ,
SCOTUS ,
Stays ,
Vaccinations ,
Virus Testing
Last week, the Centers for Medicare and Medicaid Services (CMS) and the Occupational Safety and Health Administration (OSHA) published their much-anticipated rules mandating COVID-19 vaccinations. ...more
11/9/2021
/ Americans with Disabilities Act (ADA) ,
Appeals ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Constitutional Challenges ,
Coronavirus/COVID-19 ,
Equal Employment Opportunity Commission (EEOC) ,
Executive Orders ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Workers ,
Hospitals ,
Interim Final Rules (IFR) ,
Medicaid ,
Medicare ,
New Guidance ,
Physicians ,
Popular ,
Preemption ,
Stays ,
Supremacy Clause ,
Title VII ,
Vaccinations
In 2018, the U.S. Department of Health and Human Services (“HHS”) launched what it calls a “Regulatory Sprint to Coordinated Care” to accelerate a transformation of the healthcare system, with a focus on removing “unnecessary...more
The COVID-19 pandemic has led to rapid and drastic changes to health care delivery in the United States, including as it relates to arrangements between health care providers and physicians that may implicate the federal...more
On Monday, March 23, 2020, the Center for Medicare and Medicaid Services (“CMS”) released Frequently Asked Questions on Medicare Provider Enrollment Relief related to COVID-19 (“FAQs”), available here. The recent Public...more
On March 22, 2020, the Centers for Medicare & Medicaid Services (CMS) announced in a press release that it is granting exceptions from reporting requirements and extensions for upcoming data submission and measure reporting...more
In the calendar year 2020 Medicare physician fee schedule final rule (“PFS”), which was published in the Federal Register on November 15, 2019 (available here), CMS finalized changes to the advisory opinion process under the...more
11/21/2019
/ Advisory Opinions ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Medicare ,
OIG ,
Physician Fee Schedule ,
Physicians ,
Regulatory Standards ,
Request For Information ,
Stark Law
As reported here in February, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released two new significant proposed regulations that would have had a transformative effect on the drug...more
9/10/2019
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Managed Care Contracts ,
Medicaid ,
Medicare ,
Medicare Part D ,
OIG ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Regulation ,
Safe Harbors
In a much anticipated decision, a federal judge ruled this week that the Trump Administration’s rule requiring drug manufacturers to list drug prices in television advertisements exceeds the agency’s authority.
Back in May...more
7/10/2019
/ Advertising ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Final Rules ,
Lack of Authority ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Rulemaking Process ,
Social Security Act ,
Trump Administration
For years, CMS has informally applied restrictions for hospitals which share space, equipment, staff or services in the same physical location (i.e., “co-locate”) with other hospitals or health care entities. Although these...more
On April 22, 2019, the Centers for Medicare and Medicaid Services (CMS) announced two sweeping new payment innovation models under the Primary Cares Initiatives. The models will seek to incentivize primary care and other...more
4/26/2019
/ ACOs ,
Alternative Payment Models (APM) ,
Cardiac Episode Payment Program ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Episode Payment Models (EPM) ,
Fee-for-Service ,
Health Care Providers ,
Medicaid ,
Medicare ,
Physicians ,
Request For Information ,
Value-Based Care
On May 11, 2018, President Trump gave his long-awaited speech on his administration’s plan to lower prescription drug prices. In addition, the administration published its Blueprint to Lower Drug Prices and Reduce...more
If the government does not take action and continues to pay for Medicare/Medicaid claims after it learns of non-compliance related to the claims, is the non-compliance material to the government’s decision to pay? This is a...more
1/24/2018
/ Conditions of Payment ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Federal Contractors ,
Health Care Providers ,
Implied Certification ,
Materiality ,
Medicaid ,
Medicare ,
SCOTUS ,
Universal Health Services Inc v United States ex rel Escobar
Perhaps lost amid the healthcare news coverage of competing proposals regarding “Medicare for All” and the repeal of Obamacare, the Centers for Medicare & Medicaid Services (“CMS”) last month announced the expansion of its...more
On September 7, 2017, the OIG posted an advisory opinion regarding a retail pharmacy chain’s proposal to extend to federal health care program beneficiaries the option to participate in a paid membership program that includes...more
The Centers for Medicare & Medicaid Services (CMS) released its 2018 Medicare Physician Fee Schedule proposed rule on July 13, 2017. The proposed rule, among other things, proposes to cut Medicare payments for services...more
On July 13, 2017, CMS released a proposed rule as part of its 2018 Outpatient Prospective Payment System proposals that is aimed at helping to reduce some of the burdens rural hospitals experience in recruiting physicians....more
On July 13, 2017, CMS released several proposed rules impacting health care, including the 2018 Outpatient Prospective Payment System (OPPS) proposed rule which, among other proposals, could have a significant impact on 340B...more
On June 16th, 2017, The Department of Justice (“DOJ”) announced a $53.6 million dollar settlement with Genesis Healthcare Inc. (“Genesis”) over six federal whistleblower lawsuits alleging that subsidiaries of the...more
On November 2, 2015, President Obama signed the Bipartisan Budget Act of 2015 (“Act”) into law significantly impacting how Medicare pays certain off-campus hospital departments. Specifically, Section 603 of the Act provides...more